BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 8455729 · Received March 27, 2019

    Report

    Report Number
    2916596-2019-01381
    Event Type
    Injury
    Date Received
    March 27, 2019
    Date of Event
    November 21, 2018
    Report Date
    March 27, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PATIENT'S DEATH IS COVERED UNDER MFR#: 2916596-2018-05865. MANUFACTURER'S INVESTIGATION: ANALYSIS OF THE SUBMITTED LOG FILE CONFIRMED FREQUENT PI EVENTS, ELEVATIONS IN ESTIMATED FLOW, AND AN INCREASE IN POWER OVER TIME AND A DECREASE IN AVERAGE PI OVER TIME. BASED ON PAST EXPERIENCE WITH THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM AND SIMILAR REPORTED EVENTS, THE POWER CHANGES AND DECREASE IN AVERAGE PI COULD BE INDICATIVE OF DEVICE THROMBOSIS. HOWEVER, A DIRECT CORRELATION BETWEEN HEARTMATE II LVAS, SERIAL NUMBER (B)(4), AND THESE FINDINGS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE SUBMITTED LOG FILE CONTAINS DATA FROM (B)(6) 2018 AT 13:57:50 THROUGH (B)(6) 2018 AT 14:52:16. POWER APPEARED TO INCREASE OVER TIME AND AVERAGE PI APPEARED TO DECREASE. POWER RANGED FROM 4.7-7.9 W (AVERAGE OF APPROXIMATELY 5.9 W) AND AVERAGE PI WAS BETWEEN 2.1 AND 7.8 (AVERAGE OF APPROXIMATELY 5.1) FROM THE BEGINNING OF THE FILE THROUGH (B)(6) AT 18:19:56. FROM (B)(6) AT 18:38:50 THROUGH THE END OF THE FILE, POWER RANGED FROM 5.3-10.1 W (AVERAGE OF APPROXIMATELY 8.7 W) AND AVERAGE PI WAS BETWEEN 2.4 AND 6.6 (AVERAGE OF APPROXIMATELY 4.1). ELEVATIONS IN ESTIMATED FLOW WERE ALSO CAPTURED DURING THE POWER ELEVATIONS, REACHING A MAXIMUM OF 12.0 LPM MULTIPLE TIMES THROUGHOUT THE FILE. FREQUENT PI EVENTS (127 TOTAL) WERE ALSO CONFIRMED. NO ATYPICAL ALARMS WERE CAPTURED AND THE PUMP SPEED REMAINED ABOVE THE LOW SPEED LIMIT FOR THE DURATION OF THE FILE. THE PATIENT REMAINED ONGOING ON HEARTMATE II LVAS, SERIAL NUMBER (B)(4) UNTIL EXPERIENCING A PUMP STOPPAGE AND SUBSEQUENTLY EXPIRED. THE ACCOUNT DETAILED NO EQUIPMENT WOULD BE RETURNING FOR EVALUATION. THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTION FOR USE (IFU) LISTS DEVICE THROMBOSIS AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. THIS IFU ALSO PROVIDES DETAILED INFORMATION REGARDING PUMP SPEED, POWER, FLOW, AND PI AND EXPLAINS THAT PUMP POWER IS A DIRECT MEASUREMENT OF MOTOR VOLTAGE AND CURRENT; THEREFORE, CHANGES IN PUMP SPEED, FLOW, OR PHYSIOLOGICAL DEMAND CAN AFFECT PUMP POWER. DEVICE FLOW AND POWER GENERALLY RETAIN A LINEAR RELATIONSHIP AT A GIVEN SPEED. HOWEVER, WHILE POWER IS DIRECTLY MEASURED BY THE SYSTEM CONTROLLER, THE REPORTED FLOW IS ESTIMATED, BASED ON POWER. THE IFU EXPLAINS THAT PI EVENTS MAY BE INITIATED FOR REASONS OTHER THAN TRUE SUCTION EVENTS. SOME REASONS INCLUDE SUDDEN CHANGES IN A PATIENT¿S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER AND SUDDEN CHANGES IN PUMP SPEED. THESE TYPES OF PI EVENTS ARE MORE LIKELY TO BE TRIGGERED IN CASES OF LOW PULSATILITY. THE DOCUMENT CONTAINS INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE AND OUTLINES INDICATIONS OF PUMP THROMBOSIS, AS WELL AS HOW TO RESPOND TO SUCH EVENTS. ALSO NOTED IS THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2018. IT WAS REPORTED THAT THE PATIENT EXPERIENCED POWER AND FLOW ELEVATIONS. THE ACCOUNT REPORTED THE POWER AND FLOW ELEVATIONS WERE CAUSED BY SUSPECTED PUMP THROMBOSIS. THE PATIENT RECEIVED IV HEPARIN FOR TREATMENT. AN ECHOCARDIOGRAM WAS PREFORMED ON (B)(6) 2018. THE ECHO RESULTS INDICATED NORMAL, POWER AND FLOW STABILIZED. THE INR TARGET WAS INCREASED TO 2.5-3.5. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250139 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106015 201720 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other